ORKA · Oruka Therapeutics

The thesis

Oruka Therapeutics' shares are modestly more likely to beat the S&P 500 than lag it over the next three months. The reason is a clean placebo-controlled result: ORKA-001, its long-acting psoriasis antibody, cleared skin completely in 61% of high-dose patients against 0% on placebo on 26 October 2026. The 52-week EVERLAST-A data, which the company has guided to December 2026, settle the next question: whether that clearance lasts a year without further dosing.

The rating is Medium because the Phase 2b result is strong and the company has $1.2 billion in cash and marketable securities at 30 September 2026. The December data are a binary test, and the shares already price in a successful Phase 2b. At $104.99 on 12 November 2026 they closed well above the 50-day moving average of $89.39 and 9.1% below the 52-week intraday high of $115.52 set on 19 August 2026.

Management added detail at the Stifel healthcare conference on 11 November 2026, as reported by Investing.com. The company is aiming for once-a-year dosing of ORKA-001, with a six-month option as a fallback. It gave a target range of 50% to 80% of patients holding complete clearance at one year. It is preparing for an end-of-Phase 2 meeting with regulators and expects to test ORKA-001 in Phase 3 against an active comparator, with Stelara named as a logical choice. The 9 November 2026 third-quarter report kept the timeline: December EVERLAST-A data and a Phase 3 start in the first half of 2027.

Bullish and bearish views on Oruka Therapeutics, Inc.

The bull case on Oruka Therapeutics, Inc. (ORKA), in brief: primary endpoint met against placebo. The bear case: management's own range brackets the bar.

Bull case

• Primary endpoint met against placebo. Oruka's 26 October 2026 release reported PASI 100 (complete clearance on the Psoriasis Area and Severity Index) of 61% at 600 mg, 44% at 300 mg and 43% at 37.5 mg, against 0% on placebo, in 187 randomized participants. PASI 90 reached 86% at the high dose.
• Two trials give consistent rates. The open-label EVERLAST-A trial reported PASI 100 of 63.5% (40 of 63) at Week 16 on 27 April 2026. The placebo-controlled EVERLAST-B trial reported 61% at the high dose on 26 October 2026.
• Clearance deepened after dosing ended. On 23 September 2026 Oruka reported EVERLAST-A PASI 100 of 71.4% (45 of 63) at Week 28, with no dosing after Week 4. The December 52-week data extend the same test.
• High-dose safety looks clean. On 26 October 2026 Oruka reported adverse events in 39% of high-dose participants against 43% on placebo. Three of 140 ORKA-001 participants (2%) had serious events, none in the high-dose arm and none judged treatment-related.
• Cash covers the path to filing. The 9 November 2026 release put cash, cash equivalents and marketable securities at $1.2 billion on 30 September 2026, with $44.3 million of operating cash used in the quarter. Management said on 11 November 2026 that this funds ORKA-001 to a biologics license application (BLA) and registrational work for ORKA-002.
• Coverage stayed positive after the report. BTIG kept its Buy rating and $151 price target on 10 November 2026, after the third-quarter filing, according to GuruFocus.

Bear case

• Management's own range brackets the bar. The 50% to 80% one-year complete-clearance range given on 11 November 2026 includes results below the 63.5% EVERLAST-A Week 16 rate. A December figure in the lower half of that range would meet management's goal and still show clearance fading.
• The headline rate rests on one arm. On 26 October 2026 the 300 mg and 37.5 mg arms reached 44% and 43% complete clearance, so the 61% figure comes from the high-dose arm alone. The mid-dose arm also had adverse events in 60% of participants against 43% on placebo.
• Phase 3 design is not yet agreed. Management said on 11 November 2026 that the end-of-Phase 2 meeting with regulators is still being prepared and that an active-comparator design is expected. That raises the bar for the Phase 3 trial and its cost.
• Spending is rising fast. The 9 November 2026 release showed a third-quarter net loss of $50.0 million against $30.3 million a year earlier, and research and development expense of $53.7 million against $29.0 million. Benzinga reported that the $0.63 loss per share missed the $0.60 estimate.
• Officers keep selling under trading plans. SEC Form 4 filings show chief executive Lawrence Klein sold 25,000 shares at an average $83.62 on 1 October 2026 and 25,000 at an average $95.60 on 2 November 2026. The chief medical officer, general counsel and senior vice president of finance also sold in September and October, all under Rule 10b5-1 plans after option exercises.
• Share supply can grow. A $500 million at-the-market equity program with TD Cowen has been open since the 27 August 2026 prospectus supplement, and sales under it appear only in later filings.

Price setup

The shares closed at $104.99 on 12 November 2026. They rose from $96.02 on 5 November 2026 to $109.50 on 10 November 2026, the day of the Guggenheim conference presentation. They then eased to $107.17 on 11 November 2026 and $104.99 on 12 November 2026.

The 52-week intraday high is $115.52, set on 19 August 2026; the last close is 9.1% below it. The three-month change is a fall of 5.4% from the $111.04 close on 14 August 2026, because the summer gains were given back before the October readout. The 52-week closing low is $26.38, on 13 November 2025.

As of 12 November 2026 the 50-day moving average was $89.39 and the 200-day moving average $72.30. The last close sits well above both. The price range before the 26 October 2026 readout shows in officers' Form 4 sales: an average of $80.60 on 12 October 2026, $74.81 on 15 October 2026 and $78.53 on 20 October 2026. The kill line sits below the 50-day average, inside that mid-October range. A close there would mean the shares had given back the readout move.

Catalysts ahead

• 17 November 2026: UBS Global Biopharma Conference presentation, followed by the Jefferies Global Healthcare Conference on 18 November 2026. These are the last scheduled management appearances before the December data. Any change to EVERLAST-A timing, the end-of-Phase 2 meeting or the Phase 3 comparator would be new information.
• December 2026 (company guidance): 52-week EVERLAST-A data for ORKA-001 in plaque psoriasis. Shows whether complete clearance holds to one year with no dosing after Week 4, measured against the 63.5% Week 16 and 71.4% Week 28 rates. This is the main test of the case.
• ~31 December 2026 (est.): ORKA-004, an extended half-life TL1A antibody, enters Phase 1. Starts the third program and the planned combination with ORKA-002 in hidradenitis suppurativa.
• First quarter 2027 (guidance): ORCA-SURGE Week 16 results for ORKA-002 in psoriasis, from 171 enrolled patients. Tests whether the second program can match Bimzelx-level efficacy with dosing every six months.
• First half 2027 (guidance): Planned start of the ORKA-001 Phase 3 program at 600 mg, pending regulator discussions. Confirms the path to a biologics license application. A start moved past the first half of 2027 would break the case.

What would change the view

A daily close below $82, under the 50-day moving average and back in the mid-October price range before the 26 October 2026 readout, which would show the readout gain undone. A 52-week EVERLAST-A complete-clearance rate below the 63.5% Week 16 rate, or a Phase 3 start moved past the first half of 2027, would also show the case failing.

The risks this note tracks, each with what would confirm it:

• Complete clearance fades in longer follow-up, weakening the case for once-yearly dosing. Confirmed by: December 2026 52-week EVERLAST-A data showing PASI 100 below the 63.5% Week 16 rate.
• Regulator feedback or dose choice delays Phase 3 or makes it costlier. Confirmed by: company guidance moving the Phase 3 start past the first half of 2027, or a requirement for further dose-ranging work after the end-of-Phase 2 meeting.
• At-the-market issuance adds to the supply of shares. Confirmed by: a 10-Q or prospectus supplement disclosing material sales under the $500 million TD Cowen program.
• Rising spending shortens the funded runway faster than guided. Confirmed by: quarterly operating cash use rising well above the $44.3 million reported for the third quarter of 2026 without new financing.
• A rival long-acting or oral psoriasis drug lowers the value of infrequent dosing. Confirmed by: competitor data showing comparable complete-clearance rates with dosing every six months or less often, or a strong oral IL-23 pathway result.

What it trades with

ORKA trades mainly on its own clinical news. The 23 September 2026 Week 28 release and the 26 October 2026 Phase 2b readout drove its largest recent moves. Between events the shares tend to follow sentiment toward small and mid-cap biotech, which sets funding conditions for companies that have no revenue yet.

The commercial comparison is with established psoriasis antibodies such as Johnson & Johnson's Tremfya and Stelara and AbbVie's Skyrizi. For ORKA-002, management on 11 November 2026 named UCB's Bimzelx as the benchmark, aiming for dosing every six months in psoriasis. Data from rival long-acting or oral psoriasis drugs can move ORKA, because they change how much a less frequent dosing schedule is worth.